Relative Exclusion Criteria Research Articles

Direct thrombectomy for stroke in the presence of absolute exclusion criteria for thrombolysis.

Intravenous thrombolysis (IVT)-ineligible patients undergoing direct thrombectomy tended to have poorer functional outcome as compared with IVT-eligible patients undergoing bridging therapy. We aimed to assess radiological and functional outcomes in large vessel occlusion-related stroke patients receiving direct thrombectomy in the presence of absolute exclusion criteria for IVT vs relative exclusion criteria for IVT and vs non-exclusion criteria for IVT. A cohort study on prospectively collected data from 2282 patients enrolled in the Italian Registry of Endovascular Treatment in Acute Stroke cohort for treatment with direct thrombectomy (n = 486, absolute exclusion criteria for IVT alone; n = 384, absolute in combination with relative exclusion criteria for IVT; n = 777, relative exclusion criteria for IVT alone; n = 635, non-exclusion criteria for IVT). After adjustment for unbalanced variables (model 1), ORs for 3-month death was higher in the presence of absolute exclusion criteria for IVT alone (vs relative exclusion criteria for IVT alone) (1.595, 95% CI 1.042-2.440) and in the presence of absolute exclusion criteria for IVT alone (vs non-exclusion criteria for IVT) (1.235, 95% CI 1.014-1.504). After adjustment for predefined variables (model 2: age, sex, pre-stroke mRS ≤ 1, NIHSS, occlusion in the anterior circulation, onset-to-groin time, and procedure time), ORs for 3-month death was higher in the presence of absolute exclusion criteria for IVT alone (vs relative exclusion criteria for IVT alone) (1.235, 95% CI 1.014-1.504) and in the presence of absolute exclusion criteria for IVT alone (vs non-exclusion criteria for IVT) (1.246, 95% CI 1.039-1.495). No significant difference was found between the groups as regards any type of intracerebral hemorrhage and parenchymal hematoma within 24h, successful and complete recanalization after procedure, and modified Rankin Scale score 0-2 at 3months. After adjustment for predefined variables of model 2, ORs for death were higher in the presence of recent administration of IV heparin (OR: 2.077), platelet count < 100,000/mm3 (OR: 4.798), bacterial endocarditis (OR: 15.069), neoplasm with increased hemorrhagic risk (OR: 6.046), and severe liver disease (OR: 6.124). Radiological outcomes were similar after direct thrombectomy in patients with absolute, relative, and non- exclusion criteria for IVT, while an increase of fatal outcome was observed in the presence of some absolute exclusion criterion for IVT.

Schistosomal portal hypertension: Randomized trial comparing endoscopic therapy alone or preceded by esophagogastric devascularization and splenectomy

Background. Upper gastrointestinal bleeding is a major cause of morbidity and mortality in patients with portal hypertension secondary to schistosomiasis mansoni.Aim. To evaluate the efficacy of combined surgery and sclerotherapy versus endoscopic treatment alone in the prophylaxis of esophageal variceal rebleeding due to portal hypertension in schistosomiasis.Material and methods. During a two-years period consecutive patients with schistosomiasis and a recent bleeding history were evaluated for prospective randomization. Absolute exclusion criteria were alcoholism or other liver diseases, whereas platelet count < 50,000/mm3, INR > 1.5 or presence of gastric varices were relative exclusion criteria. By random allocation 25 (group A) have received endoscopic sclerotherapy for esophageal varices alone and 22 (group B) combined treatment: esophagogastric devascularization with splenectomy followed by sclerotherapy. Interim analysis at 24 months has shown significant statistical differences between the groups and the randomization was halted.Results. Mean age was 38.9 ± 15.4 years and 58.46% were male. Mean follow-up was 38.6 ± 20.1 months. Endoscopic comparison of the size of esophageal varices before and after treatment did not show significant differences among the two groups. Treatment efficacy was assessed by the rate of recurrent esophageal variceal bleeding, that was more common in group A- 9/25 patients (36.0%) vs. 2/22 (9.0%) in group B (p = 0.029). Other complications were odynophagia, dysphagia and esophageal ulcer in group A and ascites and portal vein thrombosis in the surgical group.Conclusion. In portal hypertension due to schistosomiasis, combined surgical and endoscopic treatment was more effective for the prevention of recurrent esophageal variceal bleeding.

Intravenous thrombolysis for ischemic stroke in the Veneto region: the gap between eligibility and reality.

Intravenous thrombolysis (IVT) is the treatment of choice for most patients with acute ischemic stroke. According to the recently updated guidelines, IVT should be administered in absence of absolute exclusion criteria. We aimed to assess the proportion of ischemic strokes potentially eligible and actually treated with IVT, and to explore the reasons for not administering IVT. We prospectively collected and analyzed data from 1184 consecutive ischemic stroke patients admitted to the 22 Stroke Units (SUs) of the Veneto region from September 18th to December 10th 2017. Patients were treated with IVT according to the current Italian guidelines. For untreated patients, the reasons for not administering IVT were reported by each center in a predefined model including absolute and/or relative exclusion criteria and other possible reasons. Out of 841 (71%) patients who presented within 4.5h of stroke onset, 704 (59%) had no other absolute exclusion criteria and were therefore potentially eligible for IVT according to the current guidelines. However, only 323 (27%) patients were eventually treated with IVT. Among 861 (73%) untreated patients, 480 had at least one absolute exclusion criterion, 283 only relative exclusion criteria, 56 only other reasons, and 42 a combination of relative exclusion criteria and other reasons. Our study showed that only 46% (323/704) of the potentially eligible patients were actually treated with IVT in the SUs of the Veneto region. All healthcare professionals involved in the acute stroke pathway should make an effort to bridge this gap between eligibility and reality.

Pancreas Donor Hypernatremia: Is it Really a Risk Factor for Simultaneous Pancreas-kidney Transplantation?

IntroductionSolid organ donor hypernatremia has been classically reported to be a risk factor for cell lysis and graft damage. National criteria for pancreatic donation consider severe hypernatremia (sodium level more than 160 mEq/L) to be relative exclusion criteria. The aim of our study is to review the postoperative outcomes of our simultaneous pancreas-kidney transplantation (SPKT) sample in terms of pancreatic fistula, intra-abdominal abscesses, pancreatitis, pancreas graft thrombosis, early pancreatectomy, and reoperation rates regarding different ranges of donor sodium levels. Material and MethodsWe performed a retrospective analysis among 161 SPKTs performed in our center between the years 2001 and 2017. We compared the aforementioned postoperative variables in two situations: 1) Whether the donor pancreas sodium levels were inferior to 149 mEq/L, or equal to or greater than 150 mEq/L; and 2) If they had severe hypernatremia (considering sodium levels greater than or equal to 160 mEq/L as threshold) or not. To ensure the comparability of the groups, a second comparison was performed on new samples after using propensity score matching. A Student t test or Mann-Whitney U test was used for intergroup comparisons of quantitative variables where appropriate, whereas a χ2 test or Fisher's exact test was used to compare categorical data. ResultsNo statistically significant differences were found between the groups that relate high donor serum sodium levels with the morbidity variables included in our study or with early pancreatic graft loss. ConclusionsIn our cohort, early postoperative main morbidity and pancreas graft loss of SPKT recipients do not differ significantly regarding donor serum sodium levels.

Use of low dose of alteplase in high risk of bleeding patients

Background: Peru has had an increasing tendency in acute stroke cases, causing a huge public health impact. Acute management in our conutry is limited only to IV thrombolysis. Many of our patientes come after that 3 hours and some of them have Relative exclusion criteria for acute reperfusion. The authors present 08 patients treated with a dose of 0.6 mg/kg of rTPA, aiming to assess equal efficacy and safety than the 0.9 mg/kg dose.

Patient Selection For Acute Stroke Intravenous Thrombolysis

Stroke is a leading cause of mortality worldwide. Unfortunately its incidence is more and the age of occurrence is one decade earlier in our country, Iran. About 75-90 percent of stroke etiology is ischemic. The only approved drug treatment for eligible acute ischemic stroke (AIS) patients is thrombolytic therapy by recombinant tissue plasminogen activator (tPA). Related level of evidence is the highest (1a) and it has been approved by FDA following NINDS study since 1996. First golden time for use of tPA was less than 3 hours but later it has extended to 4.5 hours following re-analysis of the data since 2009. In the beginning, related exclusion criteria was strict considering many absolute items, however, some of them changed or removed as relative exclusion criteria by practicing and performing researches and analysis of results and it is going to be more simplified. For example, in 2013 there were 15 absolute and 10 relative exclusion criteria for intravenous thrombolysis in AIS in less than 4.5 hours period from onset of symptoms but in 2016 following publishing American heart and Stroke Association (AHA/ASA) scientific statement this criteria was more clarified and some of relative exclusion criteria removed. And finally new published researches extended this therapeutic time window to 6 hours by using mechanical thrombectomy in defined patients not responding to IV thrombolysis. In the ninth national Iranian Stroke Congress this updated criteria will be discussed.

Abstract TP76: Symptomatic Intracranial Hemorrhage After IV tPA for Acute Ischemic Stroke in Patients with Relative Contraindications

Introduction: Contraindications to IV tPA in acute ischemic stroke (AIS) limits access to a proven medical therapy. A 2015 AHA review assigned Class 3 recommendations (harm) to IV tPA for AIS patients with prior intracranial hemorrhage (pICH), stroke within the last 3 months (SW3), or low platelets (LP) defined as platelets &lt; 100,000. These recommendations, however, were based on sparse literature, notably only 4 AIS patients with pICH and 31 with LP, were reviewed. Our study further investigates the safety of IV tPA in these patient populations. Methods: We retrospectively reviewed all AIS cases treated with IV tPA at 2 academic centers from 1998-2015 and 2013-2015. Clinical data, including patient demographics, NIHSS, and relative exclusion criteria, was abstracted from each institution’s prospectively maintained stroke database. Neuroimaging and medical chart review was performed by two stroke neurologists. Results: 324 consecutive AIS patients treated with IV tPA were reviewed. We identified 12 patients who met current Class 3 exclusion criteria (eight pICH, two SW3, two LP). Two patients developed symptomatic hemorrhagic transformation and both had pICH (Table). For comparison, the symptomatic ICH rate in AIS patients receiving IV tPA without relative exclusion criteria was 2.37%, a statistically significant difference (p&lt;0.02, using Fisher’s exact test). Conclusions: 12 AIS patients with Class 3 exclusion criteria were treated with IV tPA. Our eight reported cases of IV tPA in pICH patients adds substantially to the existing literature. In this study, 25% of patients with pICH developed symptomatic ICH after IV tPA. Although the low number of eligible patients limits interpretation of our findings, continued caution when considering IV tPA for AIS patients with pICH may be warranted. More data is needed to clarify the impact these relative contraindications have on the treatment of AIS.

Perfusion computed tomography to assist decision making for stroke thrombolysis.

The use of perfusion imaging to guide selection of patients for stroke thrombolysis remains controversial because of lack of supportive phase three clinical trial evidence. We aimed to measure the outcomes for patients treated with intravenous recombinant tissue plasminogen activator (rtPA) at a comprehensive stroke care facility where perfusion computed tomography was routinely used for thrombolysis eligibility decision assistance. Our overall hypothesis was that patients with 'target' mismatch on perfusion computed tomography would have improved outcomes with rtPA. This was a prospective cohort study of consecutive ischaemic stroke patients who fulfilled standard clinical/non-contrast computed tomography eligibility criteria for treatment with intravenous rtPA, but for whom perfusion computed tomography was used to guide the final treatment decision. The 'real-time' perfusion computed tomography assessments were qualitative; a large perfusion computed tomography ischaemic core, or lack of significant perfusion lesion-core mismatch were considered relative exclusion criteria for thrombolysis. Specific volumetric perfusion computed tomography criteria were not used for the treatment decision. The primary analysis compared 3-month modified Rankin Scale in treated versus untreated patients after 'off-line' (post-treatment) quantitative volumetric perfusion computed tomography eligibility assessment based on presence or absence of 'target' perfusion lesion-core mismatch (mismatch ratio >1.8 and volume >15 ml, core <70 ml). In a second analysis, we compared outcomes of the perfusion computed tomography-selected rtPA-treated patients to an Australian historical cohort of non-contrast computed tomography-selected rtPA-treated patients. Of 635 patients with acute ischaemic stroke eligible for rtPA by standard criteria, thrombolysis was given to 366 patients, with 269 excluded based on visual real-time perfusion computed tomography assessment. After off-line quantitative perfusion computed tomography classification: 253 treated patients and 83 untreated patients had 'target' mismatch, 56 treated and 31 untreated patients had a large ischaemic core, and 57 treated and 155 untreated patients had no target mismatch. In the primary analysis, only in the target mismatch subgroup did rtPA-treated patients have significantly better outcomes (odds ratio for 3-month, modified Rankin Scale 0-2 = 13.8, P < 0.001). With respect to the perfusion computed tomography selected rtPA-treated patients (n = 366) versus the clinical/non-contrast computed tomography selected rtPA-treated patients (n = 396), the perfusion computed tomography selected group had higher adjusted odds of excellent outcome (modified Rankin Scale 0-1 odds ratio 1.59, P = 0.009) and lower mortality (odds ratio 0.56, P = 0.021). Although based on observational data sets, our analyses provide support for the hypothesis that perfusion computed tomography improves the identification of patients likely to respond to thrombolysis, and also those in whom natural history may be difficult to modify with treatment.

Minimally invasive aortic valve replacement: the "Miami Method".

For patients undergoing aortic valve replacement (AVR), a minimally invasive approach performed via a right anterior thoracotomy is the preferred method at our institution. This method has evolved over a 10-year span, being applied to over 1,500 patients with the commitment of one surgeon seeking to offer a simplistic and reproducible minimally invasive alternative. We believe that this is truly the least invasive approach to the aortic valve since it avoids sternal invasion. By virtue of being less traumatic, the morbidity is diminished and therefore the recovery is enhanced. We believe that this approach is most beneficial in the high risk patient such as the elderly, the obese, those with chronic obstructive pulmonary, chronic kidney disease and those requiring re-operative surgery. This method has proven to be safe and effective in all patients requiring isolated AVR surgery. The only relative exclusion criteria would be a porcelain aorta with the inability to cannulate the patient.

Significant residual coronary obstruction: impact on short and long-term outcomes of a cardiac rehabilitation program in coronary heart disease

Introduction: There is evidence that cardiac rehabilitation programs (CRP) exert significant benefits in patients with coronary artery disease (CAD). However, safety and influence of residual significant coronary stenosis on CRP outcomes remain unclear. Methods: We retrospectively analyzed clinical, angiographic and functional data of a total of 287 patients referenced to a CRP after an acute coronary syndrome (ACS), between September 2008 and December 2011. Incomplete revascularization (IR) was defined by the presence of residual structural stenosis in any major epicardial vessels (>70%), consequent to unfavorable anatomy to angioplasty (PCI). Pre and post CRP functional capacity was assessed using exercise stress testing metabolic equivalents (METS). A composite outcome of overall mortality and nonfatal cardiovascular events was evaluated. Furthermore, functional capacity at follow-up evaluation was estimated using the patient-reported Duke Activity Status Index (DASI). Results: We analyzed 280 patients, mostly male (88%), aged 54±10 years. Incomplete revascularization (IR) was found in 61 (23%) patients. IR patients more frequently presented previous diagnosis of coronary heart disease (CHD) (25% vs 12%, p=0.009). They and also tended to be more often women (36% vs 22%, p=0.082) and diabetic (21% vs 14%, p=0.155), although these differences were not statistically significant. Physical training in pts with IR was safe and well tolerated. Exercise capacity increased significantly in both groups (peak MET level: + 0.7±1.7, p=0.013, in IR vs 1,0±1.7, p 0.05). The mean follow-up time was 30±13 months. Both groups showed a similar perceived physical performance, using DASI estimated peak METs (8.0±1.6 [IR] vs 8.3±1.6 [CR], p>0.05). Composite endpoints were found in 36 (10%) patients and occurred more in IR patients (19% vs 13%); however, the difference was not statistically significant (p>0.05). Kaplan Meyer showed no difference in the likelihood of a cardiovascular event, between IR and CR patients (p>0.05). Conclusion: IR patients take similar advantage from a CRP and maintain an equivalent long-term functional capacity. Although signficant residual stenosis is frequently regarded as a relative exclusion criteria for cardiac rehabilitation, these patients derive similar benefits both in short and long-term functional capacity, cardiovascular morbidity and mortality.

The Incidence of Potential Candidates for Total Disc Replacement among Lumbar and Cervical Fusion Patient Populations

Study DesignRetrospective chart review.PurposeTo evaluate the incidence of potential total disc replacement (TDR) candidates among cervical and lumbar fusion patient populations using strict Food and Drug Administration (FDA) criteria and with relative exclusion criteria removed.Overview of LiteratureRecent studies suggest that the potential percentage of patients that are candidates for TDR ranges from 0-5% in lumbar fusions and 43% in cervical fusions.MethodsWe performed a retrospective chart review of 280 consecutive patients who had lumbar (n = 174) and cervical (n = 106) fusion or TDR performed by one of four independent adult orthopaedic spine surgeons. Charts were screened for investigational device exemption (IDE) inclusion/exclusion criteria and later reanalyzed excluding relative exclusion criteria, such as history of chronic medical illness, twolevel disease (cervical cases), and history of prior fusion surgery in the anatomic region.ResultsOf the 174 lumbar surgeries, 10 were TDR with Prodisc-L and 164 were lumbar fusions. The most common TDR exclusion criteria were lytic spondylolisthesis or spinal stenosis (47.7% of patients) and more than 2 level degenerative disc disease (37.9%). 14.9% had no IDE exclusion criteria and would be considered candidates for TDR. After excluding the relative lumbar exclusion criteria, this percentage increased to 25.8%. Of the 106 cervical cases, 3 had a TDR with Prodisc-C and 103 had a cervical fusion. Twenty eight percent had no IDE exclusion criteria and would be considered candidates for cervical TDR.ConclusionsA larger percentage of cervical fusion candidates are potential candidates for TDR (28%) than lumbar fusion candidates (14.9%) based on the strict IDE criteria.

Evaluation of Outcomes Among Subsets of Patients Treated With Induced Hypothermia After Cardiac Arrest in a Community Teaching Hospital

PURPOSE: The neuroprotective effects and mortality benefit of mild induced hypothermia (MIH) after cardiac arrest has been demonstrated. The impact of providing this therapy to patients who have relative exclusion criteria remains unclear.

Transplantation and Mental Retardation: What Is the Meaning of a Discrimination?

The issue of transplantation for patients affected by mental retardation (MR) has been and continues to be a matter of discussion. The recent policy of the Veneto region, a highly populated area in northern Italy, indicates that patients with MR are not eligible for any transplant of solid organs, indicating intelligence quotient (IQ) <50 as absolute and IQ <70 as a relative exclusion criteria. In the present study, we review current conceptualizations of MR, along with the current knowledge on transplantation in this population. Finally, we will review the international guidelines on this matter and discuss the social, ethical and political significance of such policy, arguing that it discriminates persons affected by MR.

SCREENING AND MONITORING FOR BLADDER CANCER: REFINING THE USE OF NMP22

While detecting bladder cancer, bladder tumor markers demonstrate improved sensitivity compared with urinary cytology but the current limitation is the low specificity and positive predictive value, that is high false-positive rate. We examined the clinical categories of the false-positive results, established relative exclusion criteria, and recalculated the specificity and positive predictive value of this assay with these criteria. A total of 608 patients considered at risk for bladder cancer presented to a urology clinic and submitted a single urine sample. Of the 608 patients 529 (87%) presented with de novo hematuria or chronic voiding symptoms without a diagnosis of bladder cancer. There were 79 (13.0%) patients being monitored with a known history of bladder cancer. Each urine sample was examined via cytology, urinalysis, culture and NMP22 protein assay. All patients underwent office cystoscopy, and transurethral resection and/or biopsy if a bladder tumor was suspected. Of the 608 patients 226 (37.2%) presented with microscopic hematuria, 143 (23.5%) with gross hematuria and 239 (39.3%) had chronic symptoms of urinary frequency or dysuria. There were 52 (8.6%) patients who had histologically confirmed bladder cancer. Of these 52 cancers NMP22 detected 46 (88.5%), whereas cytology identified only 16 (30.8%). When atypical cytology was considered positive, cytology detected 32 (61.5%) cases. In the 135 patients with increased NMP22 values the 46 identified tumors were accompanied by 89 false-positive values yielding a specificity of 83.9% and a positive predictive value of 34.1%. These false-positive results were divided into 6 clinical categories. Exclusion of these categories improved the specificity and positive predictive value of NMP22 to 99.2% and 92.0%, respectively, yielding results similar to urinary cytology (99.8% and 94.1%). Awareness and exclusion of the categories of false-positive results can increase the specificity and positive predictive value of NMP22, enhancing the clinical use of this urinary tumor marker.

EXCLUSION CRITERIA ENHANCE THE SPECIFICITY AND POSITIVE PREDICTIVE VALUE OF NMP22* AND BTA STAT [dagger

Purpose The limitation of current urinary tumor markers is the low specificity and positive predictive value, which clinically manifests as a high false-positive rate. We analyzed the false-positive data of 2 urinary tumor markers, NMP22 and the BTA stat tests. We examined the clinical categories of the false-positive results, established relative exclusion criteria, and recalculated the specificity and positive predictive value after using the exclusion criteria. Materials and Methods A total of 278 symptomatic patients who presented to a urology clinic were asked to submit a single voided urine sample. Each sample was divided into 3 aliquots of which 1 was stabilized with the NMP22 test kit stabilizer and assayed for NMP22, 1 was tested for BTA stat and 1 was sent for cytological examination. All patients subsequently underwent office cystoscopy and bladder biopsy if indicated. Results Of the 278 symptomatic patients 112 presented with microscopic hematuria, 77 gross hematuria and 89 chronic symptoms of urinary frequency or dysuria. Of 34 cases (12%) of histologically confirmed bladder cancer NMP22 detected 28 (82.4%), BTA stat 23 (67.7%) and cytology only 10 (29.4%). When atypical cytologies were considered positive, cytology then detected 19 cases (55.9%). Elevated NMP22 values were positive in 28 cases and false-positive in 44 for a specificity of 82% and a positive predictive value of 38.9%. Similarly, BTA stat test was positive in 23 cases and false-positive in 43 for a specificity of 82.4% and a positive predictive value of 34.9%. When atypical cytologies were considered positive, the specificity and positive predictive value were 93% and 55.9%. Greater than 80% of the false-positive results were clinically categorized as benign inflammatory or infectious conditions, renal or bladder calculi, recent history of a foreign body in the urinary tract, bowel interposition segment, another genitourinary cancer or an instrumented urinary sample. A category of "no known pathology" was included in analysis as a control. History of ureteral stents or any bowel interposition segment had a 100% false-positive rate. Exclusion of all 6 clinical categories improved the specificity and positive predictive value of NMP22 (95.6%, 87.5%) and BTA stat (91.5%, 69.7%), and was similar to urinary cytology. Conclusions Awareness and exclusion of the categories of false-positive results can increase the specificity and enhance the clinical usefulness of NMP22 and BTA stat tests. Similarly, treating an atypical cytology as positive can enhance the sensitivity and usefulness of urinary cytology.